Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-11 @ 4:37 PM
Study NCT ID:
NCT03351205
Status:
UNKNOWN
Last Update Posted:
2017-11-22
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-11-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-20', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adhesion information', 'timeFrame': 'Within the first 3 months after surgery', 'description': 'Intrauterine adhesions under hysteroscopy'}], 'secondaryOutcomes': [{'measure': 'Menstruation Pattern', 'timeFrame': 'Within the first 3 months after surgery', 'description': 'menstrual volume which was assessed by pictorial blood loss assessment chart'}, {'measure': 'The change of AFS score', 'timeFrame': 'Within the first 3 months after surgery', 'description': 'he American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asherman syndrome', 'hysteroscopy', 'uterine stent', 'Estrogen', 'Amnion', 'Hysteroscopic Adhesiolysis'], 'conditions': ['Intrauterine Adhesion']}, 'descriptionModule': {'briefSummary': "Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.", 'detailedDescription': 'Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-40 years；\n* previously diagnostic hysteroscopy confirmed adhesion score \\>5， according to the American Fertility Society （AFS）classification of IUA；\n* complains of menstruation disorder and reproductive dysfunction；\n* informed consent.\n\nExclusion Criteria:\n\n* premature menopause,\n* presence of other intrauterine lesions (e.g. polyps, myoma, septa), and\n* presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),\n* adhesions limited to the lower uterine cavity or the cervical canal.'}, 'identificationModule': {'nctId': 'NCT03351205', 'briefTitle': 'The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Obstetrics and Gynecology Hospital'}, 'officialTitle': 'Randomized, Controlled Trial to Assess the Efficacy of Estrogen Therapy Combined With Disposable Balloon Uterine Stent and Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis', 'orgStudyIdInfo': {'id': 'No.6-20171120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uterine cavity barrier only', 'description': 'patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.', 'interventionNames': ['Device: disposable balloon uterine stent', 'Procedure: dried biological amnion graft']}, {'type': 'EXPERIMENTAL', 'label': 'hormone', 'description': 'patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.', 'interventionNames': ['Device: disposable balloon uterine stent', 'Procedure: dried biological amnion graft', 'Drug: estradiol valerate tablets+dydrogesterone tablets']}], 'interventions': [{'name': 'disposable balloon uterine stent', 'type': 'DEVICE', 'description': 'The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.', 'armGroupLabels': ['Uterine cavity barrier only', 'hormone']}, {'name': 'dried biological amnion graft', 'type': 'PROCEDURE', 'otherNames': ['amnion membrane'], 'description': 'Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.\n\nOther Name: Human amnion membrane', 'armGroupLabels': ['Uterine cavity barrier only', 'hormone']}, {'name': 'estradiol valerate tablets+dydrogesterone tablets', 'type': 'DRUG', 'otherNames': ['Progynova+dydrogesterone'], 'description': 'oral estradiol valerate tablets+dydrogesterone tablets', 'armGroupLabels': ['hormone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Zhen', 'role': 'CONTACT', 'email': 'fcyykyb@163.com', 'phone': '+8613718210767'}], 'facility': 'Beijing Obstetrics and Gynecology Hospital，Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhu Ru, MD', 'role': 'CONTACT', 'email': 'zhuru19790202@163.com', 'phone': '13966636438'}, {'name': 'Wang Sha, MD', 'role': 'CONTACT', 'email': 'wangsha1020@163.com', 'phone': '15201556908'}], 'overallOfficials': [{'name': 'Duan Hua, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Obstetrics and Gynecology Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Obstetrics and Gynecology Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}